Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

  • NDC Code(s): 54365-400-03, 54365-400-07, 54365-400-08
  • Packager: CareFusion 213 LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 6, 2023

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  • Active ingredients

    Chlorhexidine gluconate 2% w/v

    Isopropyl alcohol 70% v/v

  • Purposes

    Antiseptic

    Antiseptic

  • Use

    for the preparation of the patient's skin prior to surgery or injection. Helps to reduce bacteria that potentially can cause skin infection.

  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    • do not use with electrocautery procedures

    Allergy alert:

    This product may cause a severe allergic reaction.

    Symptoms may include:

    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Do not use

    • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
    • for lumbar puncture or in contact with the meninges
    • on open skin wounds or as a general skin cleanser

    When using this product

    keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

    Stop use and ask a doctor if

    irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
    • maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
    • tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
    • completely wet the treatment area with antiseptic
    • dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
    • moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute. Do not blot or wipe away.
    • discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
  • Other information

    • store between 15-30 ºC (59-86 °F)
    • avoid freezing and excessive heat above 40 ºC (104 °F)
  • Inactive ingredient

    • USP purified water
  • Questions?

    • www.chloraprep.com
    • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
  • Package/Label Principal Display Panel

    Single Swabstick carton label

    PRINCIPAL DISPLAY PANEL-CARTON

    1.75ml

    SINGLE SWABSTICK

    APPLICATORS

    Clear

    Do Not Reuse

    Not made with natural rubber latex

    48 applicators

    0.06 fl. oz. (1.75 ml) each

    NDC 054365-400-07

    Cat. No. 2601000

    ChloraPrep ® One-Step

    2% w/v chlorhexidine gluconate (CHG)

    and 70% v/v isopropyl alcohol (IPA)

    Patient Preoperative Skin Preparation

    Non-sterile Solution

    Applicator is non-sterile

    Professional Use Only

    Store between 15-30 ºC (59-86 ºF)

    Avoid freezing and excessive heat

    above 40 ºC (104 ºF)

  • INGREDIENTS AND APPEARANCE
    CHLORAPREP ONE-STEP 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-400-0748 in 1 CARTON05/10/2005
    11 in 1 POUCH
    11.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:54365-400-03200 in 1 CARTON10/07/200203/31/2019
    21 in 1 POUCH
    20.67 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:54365-400-0840 in 1 CARTON06/10/2009
    33 in 1 POUCH
    31.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02155510/07/2002
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - Becton, Dickinson and Company (832696038)
    Establishment
    NameAddressID/FEIBusiness Operations
    CareFusion 213 LLC826496312manufacture(54365-400) , analysis(54365-400) , label(54365-400) , pack(54365-400) , sterilize(54365-400)
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